| 1. |
- Bello, Natalie A, et al.
(författare)
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Increased risk of stroke with darbepoetin alfa in anaemic heart failure patients with diabetes and chronic kidney disease.
- 2015
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Ingår i: European journal of heart failure. - : Wiley. - 1879-0844 .- 1388-9842. ; 17:11, s. 1201-1207
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Tidskriftsartikel (refereegranskat)abstract
- The use of an erythropoesis-stimulating agent, darbepoetin alfa (DA), to treat anaemia in patients with diabetes mellitus and chronic kidney disease was associated with a heightened risk of stroke and neutral efficacy in the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT), despite epidemiological data suggesting the contrary. However, this association has not been evaluated in another randomized, placebo-controlled trial.
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| 2. |
- Lewis, Eldrin F., et al.
(författare)
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Health-Related Quality of Life Outcomes in PARADIGM-HF
- 2017
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Ingår i: Circulation: Heart Failure. - 1941-3289 .- 1941-3297. ; 10
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Tidskriftsartikel (refereegranskat)abstract
- © 2017 American Heart Association, Inc. Background Patients with heart failure and reduced ejection fraction have impaired health-related quality of life (HRQL) with variable responses to therapies that target mortality and heart failure hospitalizations. In PARADIGM-HF trial (Prospective Comparison of ARNI [Angiotensin Receptor-Neprilysin Inhibitor] With ACEI [Angiotensin-Converting-Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in Heart Failure), sacubitril/valsartan reduced morbidity and mortality compared with enalapril. Another major treatment goal is to improve HRQL. Given improvements in mortality with sacubitril/valsartan, this analysis provides comprehensive assessment of impact of therapy on HRQL in survivors only. Methods and Results Patients (after run-in phase) completed disease-specific HRQL using Kansas City Cardiomyopathy Questionnaire (KCCQ) at randomization, 4 month, 8 month, and annual visits. Changes in KCCQ scores were calculated using repeated measures analysis of covariance model that adjusted for treatment and baseline values (principal efficacy prespecified at 8 months). Among the 8399 patients enrolled in PARADIGM-HF, 7623 (91%) completed KCCQ scores at randomization with complete data at 8 months for 6881 patients (90% of baseline). At 8 months, sacubitril/valsartan group noted improvements in both KCCQ clinical summary score (+0.64 versus -0.29; P=0.008) and KCCQ overall summary score (+1.13 versus -0.14; P < 0.001) in comparison to enalapril group and significantly less proportion of patients with deterioration (≥5 points decrease) of both KCCQ scores (27% versus 31%; P=0.01). Adjusted change scores demonstrated consistent improvements in sacubitril/valsartan compared with enalapril through 36 months. Conclusions Change scores in KCCQ clinical summary scores and KCCQ overall summary scores were better in patients treated with sacubitril/valsartan compared with those treated with enalapril, with consistency in most domains, and persist during follow-up beyond 8 months. These findings demonstrate that sacubitril/valsartan leads to better HRQL in surviving patients with heart failure. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035255.
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| 3. |
- Strömberg, Anna, 1967-, et al.
(författare)
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Psychometric Validation of the Heart Failure Caregiver Questionnaire (HF-CQ (R))
- 2017
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Ingår i: Patient. - : ADIS INT LTD. - 1178-1653 .- 1178-1661. ; 10:5, s. 579-592
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Tidskriftsartikel (refereegranskat)abstract
- Background The Heart Failure Caregiver Questionnaire (HF-CQ (R)) was developed to assess subjective outcomes of heart failure caregivers. The HF-CQ (R) comprises 21 questions on three domains, namely physical, emotional/psychological and lifestyle. The objective of this study was to evaluate the psychometric properties of the HF-CQ (R). Methods Patients (n = 150) with heart failure and their primary caregivers (n = 150) were recruited from 11 sites in USA. Caregivers completed the HF-CQ (R) and additional questionnaires, namely Caregiver Reaction Assessment, Work Productivity and Activity Impairment questionnaire, EuroQol-5 domain, and the Hospital Anxiety and Depression Scale. Patient-completed Global Impression of Severity, construct validity, concurrent validity, reliability and responsiveness of the HF-CQ (R) were also assessed. Results In the physical and lifestyle domains, all items showed acceptable validity. No high correlations between HF-CQ (R) scores and other caregiver-completed instruments, including the Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment questionnaire, EuroQol-5 domain or Caregiver Reaction Assessment, were reported. The intra-class correlation coefficient exceeded the threshold for reliability (amp;gt;0.7) across the physical well-being (0.785), emotional/psychological (0.797), lifestyle (0.787) and total scores (0.850), indicating acceptable reliability. Internal consistency results using Cronbachs alpha showed the total aggregate score of 0.942 to be reliable. In the responsiveness analyses, each of the three scales and the total score showed responsiveness to changes defined by the Caregiver Global Impression of Severity. The overall caregiver burden score increased with increased severity of illness in the cared-for patients. Conclusions The study provides initial evidence for the acceptable validity of the HF-CQ (R) as an instrument to measure heart failure caregiver burden.
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